EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003/S003 · decided 2010-10-04
Approval details
- PMA number
- P090003
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2010-05-17
- Decision date
- 2010-10-04
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN ALTERNATE STENT FINISHING PROCESS USING AN AUTOMATED SYSTEM IN PLACE OF THE CURRENT MANUAL SYSTEM.
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